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Acetabular Liners - India CDSCO Medical Device Registration

Acetabular Liners is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001059_e78bed436018a6937fba562951e00125_acf1d0797061d8bad11c21032b57f5c2. This device is marketed under the brand name R3. The license holder is Smith & Nephew Healthcare Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class D
Acetabular Liners
UID: IMP/MD/2023/001059_e78bed436018a6937fba562951e00125_acf1d0797061d8bad11c21032b57f5c2

Brand Name

R3

Device Class

Class D

Approving Authority

CDSCO

Product Information

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (R3) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

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